FDA orders new mesh implant studies

- Modern Medicine

01/14/2012 - Increased reports of complications have prompted the US Food and Drug Administration (FDA) to order new postmarket surveillance (522) studies of surgical mesh implants used to treat pelvic organ prolapse and stress urinary incontinence.

The FDA is also considering reclassifying urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse from Class II to Class III, a higher-risk category that would require clinical trials before approval.

On January 3, the agency sent 88 postmarket study orders to 33 manufacturers of surgical mesh for pelvic organ prolapse and 11 postmarket study orders to 7 manufacturers of single-incision minislings for stress urinary incontinence. The studies will address specific concerns about safety and effectiveness.

Between 2008 and 2010, FDA received more than 1,500 reports of complications with mesh implants—5 times the rate reported between 2005 and 2007—including erosion of the mesh into the vagina, bleeding, and infection. The agency has also expressed concern about whether repairing pelvic organ prolapse with mesh is more effective than nonmesh repair. An FDA Safety Communication issued on July 13, 2011 alerted the medical community to these concerns.

Vaginal Mesh Implant Lawsuit

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